Meeting the Challenge

 

Perceived Constraints:

  1. Regulatory approval delays >12 weeks approval time
  2. The low patient number access compared to Asisa, central and eastern Europe
  3. High investigator costs compared to Eastern countries
  4. Lack of infrastructure at investigator sites. As a result of these perceptions, South Africa has lost out on many clinical trial opportunities in recent years.
  • The new regulatory authority (South African Health Products Regulatory Authority) planned for 2013 is intended to have the infrastructure and resources to review and approve clinical trials in a competitive 8 week approval process. Although the regulatory authority is currently challenged in approval timelines, the regulatory authority is committed to ensuring robust review of clinical trial applications to ensure appropriate scientific review and research participant protection.

  • The advantage of South Africa is the diversity of the population. The South African population data can be used representatively in other Western Countries to support the registration of the new medicine in the respective countries. Additionally 50% of the South African population is urban based facilitating access to potential research participants. (Reference: Discovering South Africa, A high-quality medical infrastructure and low costs make South Africa--largely an untapped opportunity--an attractive alternative for conducting clinical trials. Applied Clinical Trials, Publish date: Jun 1, 2005.

  • Although there are perceived SA costs concern in comparison to India, China and Eastern Europe, South Africa has a long history in conducting clinical trials with a reputation of good quality data that supported multiple medicine registrations with international regulatory agencies. Furthermore, “As a result of the country’s lower labor costs and a favorable exchange rate, South African clinical trials typically provide a substantial cost savings compared with those conducted in North America and Europe. This is especially important for the generic manufacturers due to the high level of competition in their segment of the pharmaceutical industry.” (Reference: www.ibpassociation.org/  International Biopharmaceutical Association Publication Conducting Clinical Trials in South Africa and China: A Comparison between Advantages, Disadvantage and Difficulties)

  • Although it has been reported that there is a lack of infrastructure at investigator site, this is related to under developed research units at academic health complexes and lack of government funded research units. (Source: National Health Summit Report, DOH, 2011). South Africa has internationally recognized researchers performing clinical research in academic and private institutions. Industry and government are committed to capacity building initiatives and the development of new research sites.